China's Lummy and Desano remain under U.S. FDA scanner for API adulteration, data issues

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U.S. FDA

Chongqing Lummy Pharmaceutical and Shanghai-based Desano Pharmaceutical remain under the warning letter scanner of the U.S. FDA for good manufacturing practice (GMP) violations in data record keeping and adulterated active pharmaceutical ingredients (APIs).

In updated warning letters issued this month, two Lummy Pharmaceutical facilities in Chongqing were found to be in violation of GMP following a March inspection which cited the "failure to prevent unauthorized access or changes to data and failure to provide adequate controls to prevent manipulation and omission of data."

What's more, the FDA said that "analysts routinely aborted the ongoing tests to prevent [the] HPLC system from recording some assay and impurities test data."

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In an initial reply, the firm promised to upgrade its software and procedures. But the FDA said that was an inadequate step and the company needed to file a comprehensive investigation into the extent of the inaccuracies, conduct a risk assessment and develop a management strategy on corrective steps.

For Desano, a domestic and export maker of the API for GlaxoSmithKline ($GSK) unit ViiV Healthcare's Tivicay (dolutegravir), the FDA also found a failure to have laboratory control records with the original, unofficial analyses, "stored in a separate 'Test' folder and ... not part of the official quality control records."

The company's response in a May letter was also found inadequate and the same steps as outlined above for Lummy were ordered.

China FDA is in the midst of its own crackdown on drug manufacturing with top brass, including Minister Bi Jingquan, meeting last week for a review of quality and efficacy of generic drug manufacture and testing.

The U.S. FDA's inspection efforts of Chinese plants approved for export have been hampered for years by a slow process to get visas for inspectors, though the two regulators have taken several steps to share practices and information in the past year, including training.

- here are the FDA warning letter for Chongqing Lummy and Shanghai Desano
- here's a China FDA release on generics manufacture (Chinese language)

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